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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2020
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint # (b)(4).
 
Event Description
It was reported during insertion of the intra-aortic balloon(iab), the physician stated that the catheter would not advance over the guidewire. The customer tried different guidewire and had the same result. There was no reported injury to the patient.
 
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Brand NameSENSATION PLUS 8FR. 50CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key9991374
MDR Text Key189091063
Report Number2248146-2020-00234
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0575
Device Lot Number3000111230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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